stereotactic body radio therapy (sbrt) for early-stage non small cell lung cancer (nsclc)

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate local disease control after 2 years in patients with non-metastatic, non-operated non-small-cell lung cancer treated by radiotherapy. eligible patients will be recruited and registered consecutively (no randomization). the estimated inclusion period is approximately 24 months. the duration of the research is 4 years. the number of patients required in this multicentric prospective study is 120: * 20 patients in the sbrt-1 arm (cyberknife), * 80 patients in the sbrt-2 arm (linear accelerator-based) * 20 patients in the conformational radiotherapy arm. this is a prospective, multicentric, non comparative and non randomized study.

the main objective of this study is to do a health economic evaluation of innovating techniques in radiotherapy. sbrt is the very precise delivery of high-powered radiation to small target volumes, using multiple low-intensity beams. extremely precise patient positioning and target location is essential for accurate treatment delivery. several studies have shown a benefit of sbrt in terms of local control and progression-free survival, in particular for the treatment of cerebral metastases of limited number and size. the development of this technique is recent. the number of treatment sessions is low: 1 to 4. but the patient is exposed to a major risk of toxicity in several organs: the bronchi, the lungs, large vessels, the oesophagus and the spinal-cord. pulmonary sbrt imposes strict rules and the use of specific equipment. extra-cranial sbrt can be realized using either: * conventional linear-accelerator equipped sbrt, * cyberknife sbrt. 3 groups of treatment will be evaluated in this study: * sbrt by cyberknife, * sbrt by linear accelerator, * conformational radiotherapy (free breathing or breath holding).

Eligibility criteria:
inclusion criteria: * non-operated non-small-cell lung cancer (nsclc) (inoperable tumor or patient refusal of surgery) * cytologically or histologically proven nsclc or * primitive pulmonary tumor of unproven malignancy * macroscopically normal bronchial endoscopy, negative cytology and biopsies * and size increase on 2 successive scans (at 10-12 weeks interval) * and hypermetabolic pet-ct pattern * and absence of other proven etiology * tumor \ 1.5 cm) from large vessels, principally in the bronchus and spinal-cord * no metastasis: m0 * no lymph node involvement: n0 * functional respiratory evaluation (fre) compatible with thoracic irradiation * maximum expiratory flow-volume \> 30% theoretical value * age \>= 18 * ecog ps \<= 2 * female patients of childbearing potential: effective method of contraception * written advice of the rcp (conciliation meeting) present in the patient file * mandatory affiliation with a social security system * written, signed informed consent exclusion criteria: * previously operated tumors * previous thoracic irradiation * previous or concurrent primary malignancies at other sites (except basocellular skin cancer or cervical cancer in situ or complete remission for more than 5 years) * life expectancy \< 6 months * pregnant or lactating woman * difficult follow-up * patient deprived of freedom

Keywords: sbrt non-operated non-metastatic non-small-cell lung cancer conformational radiotherapy non-operated non-metastatic non-small-cell lung cancer